(a)Establishment.—The Secretary shall establish and implement a demonstration
project under part B of title XVIII of the Social Security Act to
evaluate the benefits of providing payment for items and services
needed for the in-home administration of intravenous immune globin
for the treatment of primary immune deficiency diseases.

(1)Duration.—Beginning not later than one year after the date of enactment
of this Act, the Secretary shall conduct the demonstration project
for a period of 3 years.

(2)Scope.—The Secretary shall enroll not more than 4,000 Medicare beneficiaries
who have been diagnosed with primary immunodeficiency disease for
participation in the demonstration project. A Medicare beneficiary
may participate in the demonstration project on a voluntary basis
and may terminate participation at any time.

(b) Duration and Scope.—

(1)Duration.—Beginning not later than one year after the date of enactment
of this Act, the Secretary shall conduct the demonstration project
for a period of 3 years.

(2) Scope.—The Secretary shall enroll not more than 4,000 Medicare beneficiaries
who have been diagnosed with primary immunodeficiency disease for
participation in the demonstration project. A Medicare beneficiary
may participate in the demonstration project on a voluntary basis
and may terminate participation at any time.

(c) Coverage.—Except as otherwise provided in this section, items and services
for which payment may be made under the demonstration program shall
be treated and covered under part B of title XVIII of the Social Security
Act in the same manner as similar items and services covered under
such part.

(d) Payment.—The Secretary shall establish a per visit payment amount for
items and services needed for the in-home administration of intravenous
immune globin based on the national per visit low-utilization payment
amount under the prospective payment system for home health services
established under section 1895 of the Social Security Act (42 U.S.C.
1395fff).

(e) Waiver Authority.—Not later than three years after the date of enactment of this
Act, the Secretary shall submit to Congress a report that contains
an interim evaluation of the impact of the demonstration project on
access for Medicare beneficiaries to items and services needed for
the in-home administration of intravenous immune globin.

(f) Study and Report to Congress.—

(1) Interim evaluation and
report.—Not later than three years after the date of enactment of this
Act, the Secretary shall submit to Congress a report that contains
an interim evaluation of the impact of the demonstration project on
access for Medicare beneficiaries to items and services needed for
the in-home administration of intravenous immune globin.

(2) Final evaluation and report.—Not later than one year after the date of completion of the
demonstration project, the Secretary shall submit to Congress a report
that contains the following:

(A) A final evaluation of the impact of the demonstration project
on access for Medicare beneficiaries to items and services needed
for the in-home administration of intravenous immune globin.

(B) An analysis of the appropriateness of implementing a new methodology
for payment for intravenous immune globulins in all care settings
under part B of title XVIII of the Social Security Act (42 U.S.C.
1395k et seq.).

(C) An update to the report entitled “Analysis of Supply,
Distribution, Demand, and Access Issues Associated with Immune Globulin
Intravenous (IGIV)”, issued in February 2007 by the Office
of the Assistant Secretary for Planning and Evaluation of the Department
of Health and Human Services.

(g) Funding.—There shall be made available to the Secretary to carry out
the demonstration project not more than $45,000,000 from the Federal
Supplementary Medical Insurance Trust Fund under section 1841 of the
Social Security Act (42 U.S.C. 1395t).

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